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A drug that stimulates the release of growth hormone reduced visceral fat in HIV-positive people by 20% over six months, without the glucose elevations or adverse events seen with recombinant human growth hormone, a large study has shown.

Stephen Grinspoon of Harvard Medical School presented final results of a study assessing the effect of growth hormone analogue TH9507 on visceral adipose tissue (VAT) in people with HIV on Monday at the Fourteenth Conference on Retroviruses and Opportunistic Infections in Los Angeles.

TH9507 is a peptide that helps stimulate the body’s production of growth hormone (GH) in a physiological manner rather than directly supplementing growth hormone. Preliminary studies show that it may have beneficial effects on the visceral fat accumulation seen with antiretroviral therapy (ART).

Visceral fat accumulation often occurs after HIV treatment is commenced, although studies comparing HIV-positive and HIV-negative men matched for age have failed to prove that it is a distinct feature of the HIV lipodystrophy syndrome.

However visceral fat accumulation contributes to the development of metabolic syndrome, and Stephen Grinspoon told a press conference that reducing abdominal fat is a justifiable clinical intervention because it has the potential to reduce cardiovascular risk.

The phase III study enrolled HIV positive people with abdominal fat accumulation related to ART. Participants were on a stable ART regimen and had documented abdominal fat accumulation: for men, a waist circumference (WC) of at least 95 cm and a waist-to-hip ratio (WHR) of at least 0.94; for women, a WC of at least 94 cm and a WHR of at least 0.88. Of the 412 participants, 275 were randomised to receive TH9507 2mg injected subcutaneously each day, while 137 received placebo injection.

Over the course of the 26-week study, change in VAT was measured by abdominal computed tomography (CT) scan. Other efficacy outcomes included triglyceride level, cholesterol-to-HDL ratio and IGF-I levels. Safety outcomes included glucose and insulin levels. The study was designed to have a 90% power to detect an 8% decrease in VAT between TH9507 and placebo.

At baseline, the population comprised 86% men, and the mean age of participants was 48 years. The mean WHR was 1.1 ± 0.1 and the mean WC was 104 ± 10 cm. Of all participants, 19% had type II diabetes or glucose intolerance.

Mean IGF-I increased significantly with TH9507 (+80% vs -5% with placebo, p < 0.001), but remained within the normal physiologic range. At week 26, there was no significant change in fasting and two-hour blood glucose and insulin levels. The number of adverse events reported by each group was not different, and the only two adverse events being reported by at least 10% of either group were headache (16% for TH9507 vs 18% for placebo, p = ns) and arthralgia (joint pain; 13% vs 10%, p = ns).

The authors conclude that TH9507 decreased VAT and improved lipid profile and “may represent a novel treatment strategy for HIV patients with central fat accumulation, including those with impaired glucose homeostasis.”

Discussing the findings, Stephen Grinspoon noted that TH9507 is less likely to interfere with glucose levels because it regulates the secretion of human growth hormone from the pituitary rather than flooding the body with supplementary growth hormone (which disrupts the feedback mechanism that regulates glucose levels, amongst other things).

H e also noted that the lipid-lowering effect seen in the TH9507 arm was better than that seen in many patients treated with lipid-lowering drugs, even though TH9507 is not a lipid-lowering agent.

A second phase III study is now taking place in Europe, and if the results confirm the findings of the first study, manufacturer Theratechnologies will seek a license for the use of TH9507 in treatment of HIV-associated visceral fat accumulation.

I guess I am a little confused...The study results were from Harvard..but now there is another study in Europe and then the company will apply for approval as an HIV treatment? Apply to the US authorities ( food and Drug) or to the European authorities??? why isn't there already an application to the US authority if the study was done here and shows favorable results??? Is this totally a manufacturer process or are the researchers also involved in the approval??

what 's the difference between serostim to this TH9507 ? cause i herd here that serostim can help to build mucsel back and on this product its not mentioned a weight loss only the fat accumulation.Can u tell?

I go in for blood test for this treatment tomorrow. Wont start for a couple of months,but they are enlisting now. I had very bad side effects from serostim and will drop this one if its anything similar. I lost no fat while on serostim, even though the drug company's tests kept indicating I was improving. I did it for a year. My joints became so stiff I needed help getting up from a sitting position. I was unable to grip by golf club my finger joints were so stiff, and whats left of my sex life suffered.

I started my injections on the second phase III of th9507 last week. It took about 5 days till I started having some joint pains and headaches.

I'm around Dallas. The study only took in 18 people here. I have enough to go 6 weeks till the next visit.From the research I've done, it sure looks like a "miracle" drug for people with lypodystrophy.

I started 3 weeks ago, and have lost almost 10lbs. My regular routine (eating, exercising) hasn't changed a bit. I can actually see my "private parts" when looking down now. That hasn't happend in almost 8 years.The side effects are almost none compared to Serostim.

Really pleased with this drug so far. I will be on it for 6 months.Its only been 1 month so far.

Tell me more tell me more :-) ... Is it just helping you get rid of the accumulated fat or is it also helping you re-build the muscle ? I am intresting of both ... I had lipo suction a year ago but there are areas such as back and you can't fix it like it used to be, it has be be gone by its nature , by the body .... how did you get it ? what was the cost ? What about the serostim ? What was your experiense with it? Were you able to build muscle and get rid of the fat as well ...

I went to the company website (Theratechnologies) and it appears that they are (will be) doing two more confirmatory Phase III studies. This looks promising. Does any one have any info on this?

I don't have any inside info, but from looking at the website I don't think they're planning on launching any other studies. The last press release (on Sept. 11th) said the FDA "indicated that it does not anticipate that additional clinical outcome trials would be required." Drug companies talk to the FDA while developing drugs and take guidance (if they're smart) so they won't be surprised by non-approval. It sounds like the FDA would consider the results of this trial enough evidence for a decision.

Theratech has already done one phase III clinical trial and have just started the second. Generally drug companies wouldn't do many phase III studies on a product, it's expensive, and if they can't get approval after all that, they toss the drug in the discard pile. Phase III is the last step before FDA approval, so it's considered the last hurdle. The good news is that the FDA sounds happy with the results so far, so maybe we'll see the drug actually approved in the next couple of years.

I did the stuff in the last phase III trial, it worked great for me. Serostim worked too, but it had a lot more side effects, I'd be a lot more comfortable taking the TH9507. So I'm keeping my fingers crossed.

I'm currently in the phase III trial. Its been 2 months of the 6 month period for me.I've had allot of improvement.This is the second phase III that they have done. The results are much more of a long term improvement over Serostim.I've done Serostim twice and had great benefits from it (with bad side effects), but it didn't last very long.

There is another 6 months after this one that they company has already approved. Not sure if its open or just to the people in this study.

But I so believe in this new drug. There is no side effects to speak of.

Hi, Can u please specify how exactly did it work for you ? What were the benefits? Was it only helping reducing the accumulated fat OR was it also helping you get back some of the volume in the leggs and bott ?Also , If it was still not approved by the fda, is there any way to get it? or only throu the trials ?

The company said its 52-week results are consistent with the safety profile observed in the first 26 weeks of treatment and show that tesamorelin is well tolerated. Tesamorelin's efficacy is also confirmed as patients on treatment for 52 weeks lost 18% of their VAT compared to baseline.

Theratechnologies extended the study to evaluate the safety profile of tesamorelin over a 52-week period. The safety profile in this extension phase replicated the safety data disclosed after 26 weeks of treatment.

The company noted that the data from its 52-week Phase 3 trial demonstrate that one-year treatment with tesamorelin results in sustained visceral adipose tissue or VAT reduction.

Yves Rosconi, President and Chief Executive Officer of the company, said, “Our objective was to demonstrate long-term safety, and we have clearly achieved this. In addition, we continue to differentiate tesamorelin from other compounds being evaluated in HIV-associated lipodystrophy as having a favorable risk/benefit profile for patients.”

It sound like great news, isn't it?Do u have any idea how long will it take before it will be approved by the FDA ? Also on some other article I read it was told this product also helps re build muscle , this is a very big issue for me, Like my whole pelvis is gone as whole mucsle is gone...but on what was published recently it was only mentioned the accumulated fat...

Yes, from the little bit I read panda it does indeed sound like potentially good news for visceral fat accumulation. I'm not convinced it's a silver bullet, but it does seem like it would reduce it by an acceptable amount. I guess it's something you'd have to keep taking forever though, or until something better comes along. And of course it's an injectable so if you hate the very idea of going on Fuzeon this may not be for you.

As far as FDA approval I'd say it will arrive at some point within the year (?) -- not sure what the normal timeline is but I was on a Phase 3 trial last year and by the year's end it was FDA approved, same thing with another med I will go on in the next month (Isentress). Obviously this expectation is reflected in Theratechnologies stock price rise yesterday.

Don't you live in Israel though? It will take longer to arrive there, correct?

Yes , I live in Israel... I realy hope it will arrive here as fast as possible, I beleive the cost will be hight and I hope to be able getting it somehow, I mean , I suffer from the lipo for about 13 years, so once something pops out and can help me, well... A year is a vely long time,but cosidering the fact I am trying to get pregnant at these days, I could not use this priduct even if it was available today for me, I have to go through the whole pregnancy time first safety, About the injections, can't I inject it to myself? I do inject myself meds. during the fertility treatment, I inject it to my belly, at the begining I didn;t want to hear about it and had to go to a nurse each time, but then sometime I had to inject it in te middle of the night and getting out of the bed for that ... so the nurse showed me how to do it, very simple and I am doing it whole by myself, BIG GIRL. By the way, talking about living in Israel... Do u know that in Israel the fertility treatments are paid by the goverment? I was sure its obvious and its all over the world but then I understand its not so there are some things good here... although we are still left behind in some issues....(specialy hiv, I think), not enought money for drugs so the cocktail's options are very limited.. so I understand u were on this clinic trial for this product? I understand you had no side effects? can u please tell me If it has also effected your body mass / muscle? I am so frustrated about it,,, no matter how I tried to "work out" to get some volume back to my leggs, nothing happened and I was hoping to be able get it back with this product as welll as loosing the accumulated fat...

Sorry its taken a bit to get back to your questions.I've been on the study now for almost 13 weeks. I've seend allot of fat loss in my stomach area. The drug stimulates the pitutary gland to produce growth hormones. Thats what firms up the "mid" section.It has no means of replacing with mass in the legs/arms.That would probably be serostim. This is only for the fat redistribution. It isn't magical either. It just takes time to disolve the accumlated fat tissues.I"ve lost almost 10 poulds in this time.I do feel better. My stomach area was a 42" (waist 31") when I started. Its now 38" (waist still 31").

They have given me an option to continue after my 6 months onto another 6 months trial.I will probably do that. But history tells us that new drugs that show this kind of promising results do get the FDA approval quickly.This is the 3rd phase III study.